Platelet Dysfunction Clinical Trial
Official title:
Cyproheptadine in Severe COVID-19 : A Unblinded Randomized Trial
This randomized controled open label clinical trial is to evaluate the effect of Cyproheptadine on the clinical course of patients presenting a severe SARS-COV 2 pneumonia.
Status | Not yet recruiting |
Enrollment | 200 |
Est. completion date | January 1, 2022 |
Est. primary completion date | November 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility | Inclusion Criteria: - Men and women age 18 or older - Hospitalized and requiring medical care for COVID-19 - Presenting respiratory failure cause by COVID 19 requiring oxygen and/or mechanical ventilation support - With radiographic evidence of pulmonary infiltrate - Able to give informed consent or, if unable to do so regarding the medical condition, having relatives able of consenting for the patient Exclusion Criteria: - Pregnancy - Patients with pre-existing terminal condition with life expectancy < 6 months - Patients with pre-existing severe lung disease requiring home O2 - History of seizure disorder - History of adverse reaction to antihistamines or to Cyproheptadine |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Ciusss de L'Est de l'Île de Montréal | Covid-19 Early Treatment Fund |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Length of hospitalization | Through study completion, an average of 1 year | ||
Primary | Need mechanical ventilation (Non invasive or Invasive) | Through study completion, an average of 1 year | ||
Secondary | Death | Day 28 | ||
Secondary | Length of hospitalization in the intensive care unit | Through study completion, an average of 1 year | ||
Secondary | Duration of mechanical ventilation | Through study completion, an average of 1 year | ||
Secondary | SOFA Score | Sequential Organ Failure Min Score 0-Max score 24 Higher scores mean a worse outcome | At Day 1,3,5,7,10 after randomization | |
Secondary | Heart rate | At Day 1,3,5,7,10 after randomization | ||
Secondary | Respiratory Rate | At Day 1,3,5,7,10 after randomization | ||
Secondary | Spo2/FiO2 and ROX ratio | At Day 1,3,5,7,10 after randomization | ||
Secondary | CRP level | At Day 1,3,5,7,10 after randomization | ||
Secondary | LDH level | At Day 1,3,5,7,10 after randomization | ||
Secondary | D-Dimere level | At Day 1,3,5,7,10 after randomization | ||
Secondary | Platelet count | At Day 1,3,5,7,10 after randomization |
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---|---|---|---|
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